Abraxane in solid tumor The clinical database included two single arm studies enrolling a total of 106 patients and one multi-center randomized trial. The multi-center trial was conducted in 460 patients with metastatic breast cancer who were randomized to receive either Abraxane 260 mg/m² administered as a 30-minute infusion or paclitaxel 175 mg/m² given over 3 hours. Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry. Seventy-nine percent had visceral metastases and 76% had > 3 sites of metastases. Fifty-nine percent of patients had received one or more prior chemotherapy regimens, and 77% had received an anthracycline-containing regimen. The objective response rate verified by central review was 21.5% (95% CI: 16.2% to 26.7%) for Abraxane compared to 11.1% (95% CI: 6.9% to 15.1%) for paclitaxel (p=0.003). The conclusion of this phase III trial is that Abraxane had statistically significant higher target lesion response rate (the trial primary endpoint) (O'Shaughnessy et al, 2003).